U.S. patent number 10,675,409 [Application Number 15/848,790] was granted by the patent office on 2020-06-09 for needleless injection device with an improved sealing gasket.
This patent grant is currently assigned to CROSSJECT. The grantee listed for this patent is CROSSJECT. Invention is credited to Xavier Vigot, Gilles Vivien.
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United States Patent |
10,675,409 |
Vivien , et al. |
June 9, 2020 |
Needleless injection device with an improved sealing gasket
Abstract
The present disclosure is directed towards a needleless
injection device including an injection system which includes at
least one injection nozzle which delimits at least one injection
channel, and which is axially delimited by an upper face arranged
facing the lower face of the reservoir, and a lower face adapted to
cooperate with a cap, and an upper sealing gasket which extends
around the at least one channel and which is housed in an upper
groove formed on the upper face of the nozzle, and the upper gasket
has a wave-shaped radial section which comprises successively,
along a radial direction, a recessed portion and a bump portion,
said bump portion being adapted to be lying toward the recessed
portion provided to this end, under the effect of the axial
pressure exerted by the lower face of the reservoir on said sealing
gasket.
Inventors: |
Vivien; Gilles (Malakof,
FR), Vigot; Xavier (Veronnes, FR) |
Applicant: |
Name |
City |
State |
Country |
Type |
CROSSJECT |
Dijon |
N/A |
FR |
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Assignee: |
CROSSJECT (Dijon,
FR)
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Family
ID: |
54356473 |
Appl.
No.: |
15/848,790 |
Filed: |
December 20, 2017 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20180110924 A1 |
Apr 26, 2018 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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PCT/FR2016/051658 |
Jun 30, 2016 |
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Foreign Application Priority Data
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Jun 30, 2015 [FR] |
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15 56161 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M
5/20 (20130101); A61M 5/3129 (20130101); A61M
5/30 (20130101); F16L 17/04 (20130101); A61M
2005/3132 (20130101) |
Current International
Class: |
A61M
5/20 (20060101); A61M 5/31 (20060101); A61M
5/30 (20060101); F16L 17/04 (20060101) |
Field of
Search: |
;604/68 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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2745619 |
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Sep 1997 |
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FR |
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2815544 |
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Apr 2002 |
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FR |
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2853837 |
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Oct 2004 |
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FR |
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2941027 |
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Jul 2010 |
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FR |
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Other References
International Search Report for International Application
PCT/FR2016/051658, dated Oct. 12, 2016. cited by applicant.
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Primary Examiner: Mehta; Bhisma
Assistant Examiner: Hussain; Nidah M
Attorney, Agent or Firm: Burris Law, PLLC
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of International Application No.
PCT/FR2016/051658, filed on Jun. 30, 2016, which claims the benefit
of and priority to FR 15/56161 filed on Jun. 30, 2015. The
disclosures of the above applications are incorporated herein by
reference.
Claims
What is claimed is:
1. A needleless injection device including an injection system that
extends axially along an injection axis and comprises at least,
from upstream to downstream along the injection axis: at least one
plunger; a reservoir that contains an active ingredient and has a
lower face; an injection nozzle, axially delimited by an upper face
arranged facing the lower face of the reservoir, and a lower face
adapted to cooperate with a cap, the nozzle delimiting at least one
injection channel extending axially from the upper face, to the
lower face of the nozzle; and an upper sealing gasket that extends
around the at least one channel, and housed in an upper groove
formed on the upper face of the nozzle, the upper sealing gasket
being configured to bear axially on the lower face of the
reservoir; wherein the upper sealing gasket has a wave-shaped
radial section that comprises successively, along a radial
direction, a recessed portion and a bump portion, said bump portion
being configured to be lying toward the recessed portion, under the
effect of an axial pressure exerted by the lower face of the
reservoir on the upper sealing gasket.
2. The needleless injection device according to claim 1, wherein
the bump portion has an oblique flank arranged opposite the
recessed portion and forms a peripheral ramp configured to allow
the lying of the bump portion of the upper sealing gasket toward
the recessed portion, under the effect of the axial pressure
exerted by the reservoir on said ramp of the upper sealing
gasket.
3. The needleless injection device according to claim 1, wherein
the recessed portion of the upper sealing gasket is arranged
radially toward an inside of the nozzle, and the bump portion of
the upper gasket is arranged radially toward an outside of the
nozzle.
4. The needleless injection device according to claim 1, wherein
the recessed portion has a shape which is complementary to the
shape of the bump portion of the upper sealing gasket.
5. The needleless injection device according to claim 1, wherein
the at least one injection channel is arranged in an offset manner
relative to the injection axis, and the upper sealing gasket forms
at least one lobe which bypasses said at least one injection
channel.
6. The needleless injection device according to claim 5, wherein
the injection nozzle delimits three injection channels which are
angularly distributed in an even manner about the injection axis,
and in that the upper sealing gasket forms three lobes, each lobe
bypassing one of said channels so that the upper sealing gasket has
a circular shape which has three circle portions, each forming one
lobe.
7. The needleless injection device according to claim 1, wherein
the upper sealing gasket is made by overmolding on the nozzle.
8. The needleless injection device according to claim 1, wherein
the upper sealing gasket is made of a thermoplastic elastomer
adapted to chemically adhere on the nozzle, wherein the nozzle is
made of polycarbonate.
9. The needleless injection device according to claim 1, further
comprising a lower gasket which extends over the lower face of the
nozzle, and which is adapted to provide sealing with a closure cap
of the nozzle, the lower gasket being integrally made with the
upper sealing gasket, wherein the lower gasket and the upper
sealing gasket are linked to one another by at least one passage
formed in the nozzle.
10. The needleless injection device according to claim 1, wherein
the active ingredient contained in the reservoir is selected from
the group consisting of: Methotrexate, Adrenaline, Sumatriptan,
Hydrocortisone, Naloxone, Midazolam, Apomorphine, Ethylnatrexone
bromide, Phytomenadione, Chlorpromazine zydrochloride,
Zuclopenthixol acetate, Danaparoid sodium, Enoxaparin sodium,
Estradiol cypionate, Medroxyprogesterone acetate, Medroparin
calcium, Methylprednisolone acetate, Heparin calcium, Terbutaline.
Description
FIELD
The present disclosure relates to a needleless injection
device.
BACKGROUND
The statements in this section merely provide background
information related to the present disclosure and may not
constitute prior art.
The technical field of the present disclosure is one of disposable
pre-filled needleless injection devices, operating with an energy
source such as a gas generator, and used for intradermal,
subcutaneous and intramuscular injections, of a liquid active
ingredient for a therapeutic use in human or veterinary
medicine.
The active ingredient is constituted of a viscous liquid, a mixture
of liquid, or a gel. The active ingredient may also be a solid
dissolved in a solvent suitable for the injection or may be
constituted of a pulverulent solid suspended at a certain
concentration in a suitable liquid. The grain size distribution of
the active ingredient is then be compatible with the diameter of
the ducts in order to avoid obstructing them.
Generally, an injection device includes, for example as disclosed
in patent application FR-A-2815544 (equivalent to WO 02/34317), a
body comprising successively a gas generator, an expansion chamber,
a reservoir containing the liquid active ingredient and an
injection system.
The reservoir is constituted by a glass tube which is inserted into
the body of the device and which is obstructed by an upstream
plunger and a downstream plunger between which the liquid active
ingredient is contained.
The downstream free end of the reservoir cooperates with an
injection nozzle which delimits at least one injection channel
extending axially along an injection axis.
The injection nozzle is axially delimited by an upper face bearing
axially on the reservoir, and a lower face adapted to cooperate
with a closure cap.
In addition, the injection device includes a hollow cover which
envelops the body and which delimits a lower opening adapted for
the passage of the injection nozzle.
In order to enable the injection of the active ingredient, the body
is slidably mounted in the cover, from bottom to top along a
sliding axis, between a rest position and an injection position,
the driving of the body being carried out when the user presses the
injection nozzle onto his skin.
The displacement of the body in the cover allows the gas generator
to be triggered, generating a pressurized gas which drives in
displacement the plungers in order to inject the active ingredient
through the patient's skin via the injection nozzle.
In order to provide the sealing between the reservoir and the
nozzle, in particular at the time of injection, an upper sealing
gasket can be used.
The upper sealing gasket extends around the injection channels and
is housed in an upper groove formed on the upper face of the
nozzle. This gasket being designed to be axially compressed between
the lower face of the reservoir and the upper face of the
nozzle.
In a known manner, the gasket has a convex domed shape which is
axially squashed by the reservoir.
It is observed that, when the gasket is compressed between the
nozzle and the tube, the gasket may overflow from its groove and
creep outwards between the nozzle and the reservoir, thereby
creating a clearance conducive to the leakage of liquid.
In addition, this type of gasket generally forms lobes which bypass
the injection channels of the nozzle, conferring a sinuous shape to
the gasket, around the injection axis.
Such a sinuous shape may promote the apparition of pinches of the
gasket when it is compressed by the reservoir, which may cause
leakage between the nozzle and the reservoir.
SUMMARY
The present disclosure aims in particular at overcoming these and
other drawbacks, and relates to a needleless injection device. In
one form, the present disclosure includes an injection system which
extends axially along an injection axis and which comprises at
least, from upstream to downstream along the injection direction:
at least one plunger; an active ingredient reservoir which has a
lower face; an injection nozzle axially delimited by an upper face
arranged facing the lower face of the reservoir; a lower face
adapted to cooperate with a cap, the nozzle delimiting an injection
channel extending axially from the upper face, to the lower face of
the nozzle; an upper sealing gasket which extends around the at
least one channel, and which is housed in an upper groove formed on
the upper face of the nozzle. The gasket is designed to bear
axially on the lower face of the reservoir. The upper gasket has a
wave-shaped radial section which comprises successively, along a
radial direction, a recessed portion and a bump portion, said bump
portion being adapted to be lying toward the recessed portion
provided to this end, under the effect of the axial pressure
exerted by the lower face of the reservoir on said the sealing
gasket.
In one form, the upper gasket according to the present disclosure
improves the sealing of the nozzle, by lying and not by squashing,
thereby inhibiting outward the pinching and the creeping of the
gasket outwards.
In another form, the bump portion has an oblique flank which is
arranged opposite the recessed portion and which forms a peripheral
ramp adapted to allow the bump portion of the upper gasket to lie
toward the recessed portion, under the effect of the axial pressure
exerted by the reservoir on said the ramp of the upper gasket.
The ramp may promote the lying of the upper gasket, by cooperating
with the lower face of the reservoir.
In another form, the recessed portion of the upper gasket is
arranged radially toward the inside of the nozzle, and the bump
portion of the upper gasket is arranged radially toward the outside
of the nozzle, which allows the upper gasket to lie toward the
center of the nozzle.
In addition, the recessed portion has a shape which is generally
complementary to the shape of the bump portion of said upper
gasket.
In one form, the injection channel is arranged in an offset manner
relative to the injection axis, and the upper sealing gasket forms
at least one lobe which bypasses said injection channel. Although
the upper gasket has a tortuous shape, it provides sealing between
the nozzle and the container when lying.
In another form, the injection nozzle delimits three injection
channels which are angularly distributed in an even manner about
the injection axis, and in that the upper gasket forms three lobes
each bypassing one of said channels, so that the upper gasket has a
generally circular shape which has three circle portions each
forming a lobe.
According to yet another form, the upper gasket is made by
overmolding on the nozzle, and the upper gasket is made of a
thermoplastic elastomer adapted to chemically adhere on the nozzle
made of polycarbonate.
In one form, the present disclosure includes an additional lower
gasket which extends over the lower face of the nozzle, and which
is adapted to provide the sealing with a closure cap of the nozzle,
the lower gasket being integrally made with the upper gasket, said
gaskets being linked to each other by at least one passage,
provided to this end, formed in the nozzle.
According to another form, the active ingredient contained in the
reservoir is selected from the group comprising the following
active ingredients: Methotrezate, Adrenaline, Sumatriptan,
Hydrocortisone, Naloxone, Midazolam, Apomorphine, Ethylnatrexone
bromide Phytomenadione, Chlorpromazine hydrochloride,
Zuclopenthixol acetate, Danaparoid sodium, Enoxaparin sodium,
Estradiol cypionate, Medroxyprogesterone acetate, Medroparin
calcium, Methylprednisolone acetate, Heparin calcium,
Terbutaline.
Further areas of applicability will become apparent from the
description provided herein. It should be understood that the
description and specific examples are intended for purposes of
illustration only and are not intended to limit the scope of the
present disclosure.
DRAWINGS
In order that the disclosure may be well understood, there will now
be described various forms thereof, given by way of example,
reference being made to the accompanying drawings, in which:
FIG. 1 is an axially exploded perspective view, which illustrates a
needleless injection device, according to the present
disclosure;
FIG. 2 is a top perspective view, which illustrates the nozzle of
FIG. 1 equipped with an upper sealing gasket;
FIG. 3 is a schematic cross-sectional view, which illustrates the
nozzle of FIG. 1 equipped with a sealing gasket;
FIG. 4 is a bottom perspective view, which illustrates the lower
face of the injection nozzle provided with a lower gasket;
FIG. 5 is a detail cross-sectional view, which illustrates a
portion of the gasket of FIG. 2 at rest;
FIG. 6 is a detail cross-sectional view, which illustrates a
portion of the gasket of FIG. 2 lying by the reservoir; and
FIG. 7 is a perspective view which illustrates the gasket of FIG. 2
in its entirety.
The drawings described herein are for illustration purposes only
and are not intended to limit the scope of the present disclosure
in any way.
DETAILED DESCRIPTION
The following description is merely exemplary in nature and is not
intended to limit the present disclosure, application, or uses. It
should be understood that throughout the drawings, corresponding
reference numerals indicate like or corresponding parts and
features.
In the following, the longitudinal, vertical, and transverse
terminologies is adopted without limitation with reference to the
trihedron L, V, T indicated in the figures.
In addition, in the present application, the terms "upper",
"lower", "horizontal", "vertical", and their derivatives refer to
the position or orientation of an element or a component, this
position or orientation being considered with reference to the
orientation of the device in the figures and to the trihedron L, V,
T, without reference to the earth's gravity.
Similarly, the terms "axial" and "radial" should be understood with
reference to the injection axis B of the injection device.
In all these figures, identical or similar reference numerals
represent identical or similar members or sets of members.
FIG. 1 shows a needleless injection device 10, or needleless
syringe, which includes a U-shaped body 12 comprising successively
a percussion device 14, a gas generator 16 comprising a primer 18
and a pyrotechnic charge 20, an expansion chamber 22, a reservoir
24 containing the liquid active ingredient 26 and an injection
nozzle 28.
The percussion device 14 and the gas generator 16 constitute a
first linear subassembly of the body 12 which extends axially along
a vertical sliding axis A, and the reservoir 24 containing the
active ingredient 26 and the injection nozzle 28 form a second
linear subassembly of the body 12 which extends axially along a
second vertical injection axis B.
These two subassemblies are linked to one another by the expansion
chamber 22 which has an axis perpendicular to the axes A, B of the
subassemblies.
The reservoir 24 is constituted by a glass tube 30 obstructed by an
upstream plunger 32 and a downstream plunger 34 between which the
active ingredient 26 is contained, the plungers being made of an
elastically-deformable elastomer-based material.
The reservoir 24 extends axially from a lower collar 36 which has
an annular lower face 38 arranged opposite the injection nozzle 28,
to an upper collar 40 having an annular upper face 42.
Also, according to FIG. 1, a cylindrical flexible diaphragm 44
includes an annular seat 46 which is axially interposed between the
upper collar 40 of the reservoir 24 and the outlet orifice of the
expansion chamber 22, and a cylindrical body 48 which extends
axially inside the reservoir 24, above the upstream plunger 32.
The body 48 of the diaphragm 44 is designed to extend axially,
under the effect of the pressure of the gas generated by the gas
generator 16, in order to push the upstream plunger 32.
Referring to FIG. 1, the body 12 is enveloped by a hollow cover 50
which delimits a lower opening closed by a horizontal base 52
forming a cover bottom.
The base 52 delimits a circular passage 54 about the injection axis
B which is adapted for the passage of the injection nozzle 28 and
of the downstream end of the body 12, so that the nozzle 28
includes a lower section protruding vertically downwards out of the
cover 50.
Also, the injection device 10 is equipped with a stopper 58 which
is removably mounted on the body 12 by a bayonet-type locking
means.
The injection nozzle 28, illustrated in FIGS. 2 and 3, has a
generally cylindrical shape which extends axially along the
injection axis B from an upper face 60 bearing axially on the lower
face 38 of the reservoir 24, to an injection lower face 62 adapted
to cooperate with a closure cap 64.
The cylindrical peripheral face 66 of the nozzle 28 has a thread 68
designed to screw the nozzle 28 on the free end of the body 12
equipped with a complementary tapping 70 shown in FIG. 1.
The nozzle 28 delimits three axial injection channels 72 which
extend parallel to the injection axis B and which are angularly
arranged in an even manner about the injection axis B, each channel
72 opening into the upper face 60 and into the lower face 62 of the
nozzle 28.
The lower free end of each channel 72 forms a mouthpiece protruding
axially from the lower face 62 of the nozzle 28.
In addition, the nozzle 28 delimits a central housing 74 which is
adapted to receive the downstream plunger 34 subsequently to the
triggering of the injection.
More particularly, the upper free end of each channel 72 forms a
flaring 73 which communicates with the housing 74, to allow the
active ingredient 26 to penetrate into each channel 72, from the
housing 74.
Indeed, when the gas generator 16 is triggered, the pressurized gas
pushes the liquid column formed by the upstream plunger 32, the
active ingredient 26 and the downstream plunger 34, the downstream
plunger 34 falling in the housing 74 of the nozzle 28 provided to
this end to allow the active ingredient 26 to flow through the
channels 72.
Also, the nozzle 28 is equipped with three hooks 76 which extend
upwards from the upper face 60 of the nozzle 28 and which are
adapted to cooperate with the lower collar 36 of the reservoir
24.
In order to provide the sealing between the nozzle 28 and the
reservoir 24, the injection device 10 includes an upper sealing
gasket 78 which extends about the injection axis B, and about the
three channels 72, the upper gasket 78 being housed in a
complementary upper groove 80 formed on the upper face 60 of the
nozzle 28.
As shown in FIG. 2, the upper gasket 78 forms three lobes 82 each
bypassing an associated channel 72, so that the upper gasket 78 has
a generally circular shape which has three circle portions forming
the lobes 82.
Referring to FIGS. 3 and 5, the upper gasket 78 has a wave-shaped
radial section which comprises successively, along a transverse
radial direction, a recessed portion 86 arranged radially toward
the center of the nozzle 28, and a bump portion 88 arranged
radially toward the outside of the nozzle 28.
The bump portion 88 is adapted to be lying toward the recessed
portion 86 provided to this end, under the effect of the axial
pressure exerted by the lower face 38 of the reservoir 24 on the
upper gasket 78, as illustrated in FIG. 6.
To this end, the bump portion 88 of the upper gasket 78 has an
oblique flank which is arranged opposite the recessed portion and
which forms a peripheral ramp 90 adapted to allow the folding, or
the lying, of the bump portion 88 toward the recessed portion 86,
under the effect of the axial pressure exerted by the reservoir 24
on the ramp 90.
The ramp 90 extends from bottom to top, radially toward the center
of the nozzle 28.
The term "lying", related to the bump portion 88 of the upper
gasket 78, means herein that the bump portion 88 is inclined toward
the recessed portion 86, unlike a gasket which squashes and
creeps.
In addition, the recessed portion 86 has a shape which is generally
complementary to the shape of the bump portion 88 of the upper
gasket, forming a housing in which the bump portion 88 can lie, at
least partially.
According to another aspect illustrated in FIGS. 4 and 7, the
injection device 10 includes an additional lower gasket 94 which
extends over the lower face 62 of the nozzle 28 and which is
adapted to provide the sealing with the closure cap 64 of the
nozzle 28.
For this purpose, as shown in FIG. 3, the lower gasket 94 is in the
form of a radial planar disc which is adapted to bear axially on an
axially protruding annular ridge 96 which is formed by the cap 64
and which extends about the injection axis B.
Also, the lower gasket 94 delimits three holes 98 for the passage
of the mouthpieces 100 of each channel 72.
The lower gasket 94 and the upper gasket 78 are integrally made by
overmolding on the nozzle 28, of a thermoplastic elastomer.
To this end, the nozzle 28 delimits three passages 102 (one of
which is represented in FIG. 3) each linking the upper groove 80
formed on the upper face 60 of the nozzle 28 and the lower face 62
of the nozzle 28, in order to allow making the lower gasket 94 and
the upper gasket 78 into one piece by overmolding on the nozzle
28.
Advantageously, the nozzle 28 is made by molding of polycarbonate
and the elastomer used to make the upper gasket 78 and the lower
gasket 94 is adapted to chemically adhere with the polycarbonate
forming the nozzle 28.
According to one form, the upper gasket 78 and the lower gasket 94
are made of a thermoplastic elastomer with a 70 Shore A hardness,
and a 650 percent elongation at break.
The description of the disclosure is merely exemplary in nature
and, thus, variations that do not depart from the substance of the
disclosure are intended to be within the scope of the disclosure.
Such variations are not to be regarded as a departure from the
spirit and scope of the disclosure.
* * * * *